Trial Outcomes & Findings for A Phase II Trial of OSI-906 and Sorafenib in Advanced Hepatocellular Cancer (NCT NCT01334710)

Results Overview

Efficacy will be measured by evaluating the number of patients who do not have disease progression (measured by CT or MRI scan) 5 months after starting treatment. Assessment of the endpoint of disease progression will be performed every 2 months using either CT or MRI scan. Participants will remain on the study until either evidence of disease progression or unacceptable side effects develop. This period is expected to be on the average 6 months long.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

6 months

Results posted on

2017-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	Sorafenib and OSI-906 This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients. Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Sorafenib and OSI-906 This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients. Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily
Overall Study Trial was terminated	3

Baseline Characteristics

A Phase II Trial of OSI-906 and Sorafenib in Advanced Hepatocellular Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sorafenib and OSI-906 n=3 Participants This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients. Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Trial was terminated early.

Efficacy will be measured by evaluating the number of patients who do not have disease progression (measured by CT or MRI scan) 5 months after starting treatment. Assessment of the endpoint of disease progression will be performed every 2 months using either CT or MRI scan. Participants will remain on the study until either evidence of disease progression or unacceptable side effects develop. This period is expected to be on the average 6 months long.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days from study entry

Evaluate the proportion of participants treated with OSI-906 and sorafenib who develop serious adverse events.

Outcome measures

Outcome measures
Measure	Sorafenib and OSI-906 n=3 Participants This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients. Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily
Toxicity Assessment	0 Participants

Adverse Events

Sorafenib and OSI-906

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bassel El-Rayes

Emory University

Phone: 404-778-1900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place